Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
HelminthiasisThe purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.
Impact of Repeated Anthelmintic Treatment on the Risk of Malaria in Kenyan School Children
Intestinal HelminthiasisAscariasis2 moreMany school children in Kenya are infected with plasmodia and helminth species and are at risk of coinfection. It has been suggested that the immune response evoked by helminth infections may modify immune responses to plasmodia species and consequently alter infection and disease risks. However, studies conducted to date have been typically cross-sectional and produced conflicting results, and there is a need for longitudinal studies to better understand the clinical consequences for individuals harbouring coinfection. This study aims to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus annual treatment on the risk of clinical malaria and on immune responses among school children aged 5-14 years in Western Province. Specifically, this study aims to investigate the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in school children, assessed using active case detection; (ii) the prevalence and density of Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and helminth specific immune responses. The study hypothesis is that intensive anthelminthic treatment among children infected with either Ascaris lumbricoides or hookworm modifies human host immune responses to plasmodia and helminth infections, and therefore alters the risk of Plasmodium infection and clinical disease. This individually randomised trial will recruit 1,450 children aged 5-14 years found to be infected with either Ascaris lumbricoides or hookworm species. Recruited children will be randomized to receive albendazole treatment either every three months or annually and monitored through periodic surveillance for clinical malaria episodes over 18 months. In addition, blood samples will be collected from sub-sample of children and screened for malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.
An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths
HelminthiasisThe prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.
Assessment of Drug Efficacy of Local Albendazole
HelminthiasisInfections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)
The Effect of an Urban Sanitation Intervention on Child Health
DiarrheaHelminthiasisThe purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.
Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance...
Soil-transmitted Helminth InfectionsSoil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The specific objectives of the first work package are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance. This study will be conducted at four different sites (Ethiopia, Tanzania, Lao PDR and Brazil) and will focus on school-aged children (age 5-14). At baseline subjects will be asked to provide a recent stool sample which will be processed using 3 different microscopic techniques (KK, Mini-Flotac and FECPAKG2). All children will be treated with a single-oral dose of albendazole (ALB) 400 mg and 14-21 days after treatment, a second stool sample will be collected from all children to again determine the fecal egg counts. At each sampling, stool is stored in preservative. Stored stool will be shipped to Belgium for DNA extraction and quantitative PCR (qPCR) analysis. A subset of the samples will be analysed by pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene. Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
DiarrhoeaSoil-transmitted Helminth Infection1 moreThe study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.
Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura...
HelminthiasisThe aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).
Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health
HelminthiasisDiarrhea1 moreThe purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.
Iron and Vitamin A in School Children
AnemiaIron Deficiency3 moreThe WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing. The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.